BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSB GROWTH MEDIA

    MDR report key: 2993981 · Received February 20, 2013

    Report

    Report Number
    MW5029224
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    Q.I. MEDICAL, INC
    Product Code
    JSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    IT WAS DISCOVERED THAT A SOY BROTH GROWTH MEDIA USED TO ASSESS STERILITY OF IV PREPARATIONS WAS ALREADY CONTAMINATED WITH BACTERIA BEFORE ANY IV PRODUCT WAS INTRODUCED INTO THE GROWTH MEDIA. THIS IS A PROBLEM THAT PREVENTS THE PHARMACY FROM BEING ABLE TO ACCURATELY DETERMINE IF IV PREPARATIONS ARE STERILE OR CONTAMINATED. THE PRODUCT IS TSB GROWTH MEDIA 100ML - LOT#1129001; EXP: OCT 13, MANUFACTURED BY (B)(4). DATES OF USE: (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73329 TSB GROWTH MEDIA TSB GROWTH MEDIA JSC Q.I. MEDICAL, INC 1129001

    Patients

    Seq Age Sex Outcome Treatment
    1